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Next-generation AIDS vaccine for healthy individuals being tested for safety, tolerability at UC Davis

d as a comparison. Neither the volunteers nor the research staff will know which product is being administered. Participants receive the test vaccine by muscle injection.

Initial safety and tolerability studies of the HIV-1 gag DNA vaccine were done in animals and more than 30 healthy volunteers. These studies have shown the vaccine to be generally safe and well-tolerated. The most common symptoms reported have been injection site pain and headache. Merck is currently conducting another study in healthy volunteers using the adenovirus vaccine, which has been very safe to date. Information from this study is still being collected.

UC Davis researchers emphasize that this trial involves a test vaccine. They will not enroll anyone whose motive for participation is to use the vaccine as a reason to increase risky behaviors by counting on the vaccine to act as protection against HIV. Participating in this trial is one way to make an important contribution to HIV vaccine research, said Evans. It will take a sustained and probably lengthy effort to develop a vaccine that stops HIV in United States and around the world. This trial is an important step in reaching that goal.

TO PARTICIPATE IN THE STUDY, volunteers must be healthy males or females between the ages of 18 and 50 who currently are HIV-negative and at low risk for acquiring HIV infection. Individuals who are pregnant or nursing, or who have hepatitis C or hepatitis B infection are not eligible for the study.

Study participants will visit UC Davis Medical Center 17 times over an 18-month period to receive a series of two vaccine injections. Blood and urine samples will be taken and other tests conducted at regular intervals. All volunteers will receive extensive counseling that will focus on reducing the chance of becoming exposed to HIV.


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Contact: Carole Gan
cfgan@ucdavis.edu
916-734-9047
University of California, Davis - Health System
12-Oct-2001


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